基于BMJ发表的一项关于针刺治疗偏头痛的随机对照试验探讨安慰针刺的优化  

Discussion of optimization of sham acupuncture setting based on a clinical trial about acupuncture treatment of migraine published in British Medical Journal

作　　者：胡汉通 胡天烨 李邦伟[1] 韩德雄[1] 高宏[1] HU Han-tong;HU Tian-ye;LI Bang-wei;HAN De-xiong;GAO Hong(The Third Affiliated Hospital of Zhejiang U-niversity of Chinese Medicine,Hangzhou 310000,China;Zhejiang University of Chinese Medicine,Hangzhou 310000;The First Hospital of Jiaxing City,Jiaxing 314000,Zhejiang Province)

机构地区：[1]浙江中医药大学附属第三医院,杭州310000 [2]浙江中医药大学,杭州310000 [3]嘉兴市第一医院,浙江嘉兴314000

出　　处：《针刺研究》2021年第7期631-634,共4页Acupuncture Research

基　　金：浙江省自然科学基金项目(No.19H270053);浙江省中医药基金项目(No.2019ZA065)。

摘　　要：在针刺随机对照研究中,对照组的合理设置直接关系到研究结果的正确解读。为了解答针刺效应是否超越安慰剂,即针刺是否具有特异性效应的问题,如何设置科学可行的安慰针刺对照组一直是研究的热点和难题。本文结合目前常用的安慰针刺类型,对2020年发表在British Medical Journal上的1项关于针刺治疗无先兆偏头痛的随机对照试验中安慰针刺方法和成功施盲要素进行深入分析,并对如何在针刺治疗痛证中优化安慰针刺提出思考,以期为针刺临床研究提供参考。In the randomized controlled clinical trials of acupuncture,the setting of the control group(sham acupuncture)directly affected the interpretations about their outcomes(beyond placebo),and has been being the hot spot and difficult problem.In the present paper,we discussed various types of sham acupuncture(invade and non-invade needling)commonly used nowadays and made an in-depth analysis on the factors contributing to the successful blinding to patients with episodic migraine without aura in a clinical study published in British Medical Journal(2020,368:m697).Moreover,we put forward some thoughts on how to optimize the setting of sham acupuncture in the treatment of pain diseases.These thoughts are 1)setting different placebo control group for different types of pain,2)selecting conventional acupoints not associated with the disease,3)selecting the most sui-table type of placebo acupuncture through pre-tests,4)choosing the distal non-meridian and non-acupoint not in the same neuronal segment with the pain locus when using non-invade consolation needling,5)trying best to reduce the patients’doubts about placebo acupuncture operation,6)selecting subjects with little or without acupuncture experience for multicenter studies,and 7)trying best to select objective indicators and to avoid the subjects’report bias when evaluating the effects of acupuncture and consolation acupuncture.

关 键 词：安慰针刺 疼痛 随机对照试验 盲法 

分 类 号：R245-3[医药卫生—针灸推拿学]